SECTION IV. DEFINITIONS
For the purpose of these Regulations, the following terms are defined:
A. "Acid Food or Acidified Food" means foods that have an equilibrium pH of 4.6 or below.
B. "Act" means Act 415 of 1953, the Arkansas Food, Drug and Cosmetic Act.
C. "Adequate" means that which is needed to accomplish the intended purpose in keeping with good public health practice.
D. "Batter" means a semi-fluid substance, usually composed of flour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods.
E. "Blanching", except for tree nuts and peanuts, means a pre-packaging heat treatment of food stuffs for a sufficient time and at a sufficient temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or bio-chemical changes in food.
F. "Corrosion-resistant" means capable of maintaining original surface characteristics under prolonged influence of the food to be contacted, the normal use of cleaning compounds and bactericidal solutions, and other conditions-of-use.
G. "Critical Control Point" means a point in a food process where there is a high probability that improper control may cause, allow, or contribute to a hazard or filth in the final food or decomposition of the final food.
H. "Department" means the Arkansas Department of Health and its duly designated representatives.
I. "Easily Cleanable" means that surfaces are readily accessible and made of such materials and finish and so fabricated that residue may be effectively removed by normal cleaning methods.
J. "Employee" means the permit holder, any individual having supervisory or management duties and any other person working in a food establishment.
K. "Equipment" means stoves, ovens, ranges, hoods, slicers, mixers, meat blocks, tables, counters, refrigerators, sinks, dishwashing machines, steam tables, and similar items other than utensils, used in the operation of a food establishment.
L. "Food" means any raw, cooked, or processed edible substance, ice, beverage or ingredient used or intended for use or for sale in whole or in part for human consumption.
M. "Food Contact Surfaces" means those surfaces of equipment and utensils with which food normally comes in contact, and those surfaces from which food may contact drain, drip, or splash back onto surfaces normally in contact with food.
N. "Food Processing Establishment" means a commercial establishment in which food is manufactured or packaged for human consumption.
O. "Hazardous Substance" means any substance or mixture of substances which is toxic, corrosive, an irritant, strong sanitizer, flammable or which generates pressure through decomposition.
P. "Imminent Public Health Hazard" means a situation which creates a risk posing" a significant threat to public health. Such hazards should not continue while a hearing or other formal proceeding is pending.
Q. "Manufacture" means the process of combining or purifying articles of food and packing same for sale to the consumer, either by wholesale or retail. Any firm, person, or corporation who represents itself as responsible for the purity and the proper labeling of any article of food by placing or having placed its name and address on the label of any food shall be deemed a manufacturer and shall be included within the meaning of these rules.
R. "Microorganism" means yeasts, molds, bacteria and viruses and includes, but is not limited to, species having public health significance. The term "undesirable microorganisms" includes those microorganisms that are of public health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated.
S. "Non-Food-Contact Surfaces" means surfaces of equipment not intended for contact with food, but which are being exposed to splash or food debris or which otherwise require frequent cleaning, shall be designed and fabricated to be smooth, washable, free of unnecessary ledges, projections, or crevices, and readily accessible for cleaning, and shall be of such material and in such repair as to be easily maintained in a clean and sanitary condition.
T. "Operator" means any person, partnership, corporation, association, cooperative or other business unit having the direct and primary responsibility for the construction, maintenance and operation of a food storage or food manufacturing plant or warehouse.
U. "Packaging" means any covering, wrapper, or container in which a product is placed for retail or wholesale distribution, either before or after sale, to a consumer. Packaging shall not be construed to include the inner wrapper.
V. "Perishable Foods" means any food of such type or in such condition or physical state that it may spoil or otherwise become unfit for human consumption.
W. "Person" means an individual, corporation, business trust, estate, trust, partnership, association, or any other public or private entity.
X. "Personnel" means all persons employed by a food manufacturer, who do or may in any manner handle or come in contact with the handling, storage, transporting, selling or distributing of food.
Y. "Pest" means any objectionable animal or insect including, but not limited to, birds, rodents, flies and larvae.
Z. "Plant" means the building or facility or parts thereof, used for or in connection with the manufacturing, packaging, labeling or holding of human food.
AA. "Potentially Hazardous Food" means any food that consists in whole or in part of milk or milk products, eggs_, meat, poultry, fish, shellfish, edible crustacean, or other ingredients, including synthetic ingredients, in a form capable of supporting rapid and progressive growth of infectious or toxigenic microorganisms. The term does not include foods which have a pH level of 4.6 or below or a water activity (aw) value of 0.85 or less.
BB. "Processing" means the preparing of a food in a manner which changes the food from its original state.
CC. "Processor" means any person processing food.
DD. "Quality Control Operation" means a planned and systematic procedure for taking actions necessary to prevent food from being adulterated.
EE. "Reconditioning" means any appropriate process or procedure by which distressed merchandise can be brought into compliance with the standards of the Department for consumption or use by the public.
FF. "Refuse" means all garbage, trash, and rubbish not intended for reuse as salvaged merchandise.
GG. "Rework" means clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food.
HH. "Safe Moisture Level" is a level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, storage and distribution. The maximum safe moisture level for a food is based on its water activity (aw). An aw will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given aw will not support the growth of undesirable microorganisms.
II. "Safe Temperatures" as applied to potentially hazardous food means food temperature of 45 degrees F. or below or 140 degrees F. or above.
JJ. "Sale or Distribution" means the act of selling or distributing, whether for compensation or not, and includes delivery, holding or offering for sale, transfer, or other means of handling or trafficking.
KK. "Sanitization" means adequate treatment of surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance and in substantially reducing the number of other microorganisms. Such treatment shall not adversely affect the product and shall be safe to the consumer.
LL. "Single-Service Articles" means cups, containers, lids, closures, plates, knives, forks, spoons, stirrers, paddles, straws, placemats, napkins, doilies, wrapping materials, toothpicks and similar articles, intended to be discarded after one use.
MM. "Utensil" means any implement used in the storage, preparation, transportation or service of food.
NN. "Vehicle" means any car, truck, bus or other means by which food or distressed, salvageable or salvaged merchandise is transported from one location to another.
OO. "Water Activity" (aw) is a measure of the free moisture in a food and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature.
PP. "Wholesome" means in sound condition, clean, free from adulteration and otherwise suitable for human consumption.
SECTION VII. SANITARY OPERATIONS.
A. General maintenance.
Buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated within the meaning of the Act. Cleaning operations shall be conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials.
B. Substances used in cleaning and sanitizing.
Approved cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures shall be free from undesirable microorganisms and shall be safe and adequate under the conditions of use. Compliance with this requirement may be verified by any effective means including purchase of these substances under a supplier's guarantee or certification, or examination of these substances for contamination. Only the following toxic materials that are required to maintain sanitary conditions may be used or stored in a plant where food is processed or exposed:
(a) Those required to maintain clean and sanitary conditions;
(b) Those necessary for use in laboratory testing procedures;
(c) Those necessary for plant and equipment maintenance and operation; and
(d) Those necessary for use in the plant's operations.
C. Poisonous or Toxic Materials.
(1) Toxic cieaning compounds, sanitizing agents, and pesticide chemicals shall be identified, held, stored and used in a manner that protects against contamination of food, food contact surfaces, or food-packaging materials.
(2) Insecticides and rodenticides shall be stored or located as to be separated physically from detergents, sanitizers, cleaning and drying agents, caustics, acids, polishes and other chemicals.
(3) Containers of poisonous or toxic materials shall be prominently and distinctly labeled according to law for easy identification of contents.
(4) Poisonous and toxic materials shall only be used in full compliance with the manufacturer's labeling.
D. Pest control.
No pests or animals shall be allowed in any area of a food plant. Guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packing materials. Effective measures shall be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials.
E. Cleaning and sanitization of food-contact and non-food-contact surfaces.
All food-contact surfaces of equipment and utensils and non-food-contact surfaces of equipment shall be cleaned and sanitized as frequently as necessary to protect against contamination of food.
(1) Food-contact surfaces used for manufacturing or holding low-moisture food shall be in a dry, sanitary condition at the time of use. When the surfaces are wet-cleaned, they shall, when necessary, be sanitized and thoroughly dried before subsequent use.
(2) In wet processing, when cleaning is necessary to protect against the introduction of microorganisms into food, all food-contact surfaces shall be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and food-contact surfaces of the equipment shall be cleaned and sanitized as necessary.
(3) Non-food-contact surfaces of equipment used in the operation of food plants should be cleaned and sanitized as frequently as necessary to protect against contamination of food.
(4) Single-service articles should be stored in appropriate containers and shall be handled, dispensed, used and disposed of in a manner that protects against contamination of food or food-contact surfaces.
(5) Where necessary to prevent the introduction of undesirable microbiological organisms into food products, at! utensils and food-contact surfaces of equipment used in the plant shall be cleaned and sanitized prior to such use and following any interruption during which such utensils and contact surfaces may have become contaminated. Where such equipment and utensils are used in a continuous production operation, the contact surfaces of such equipment and utensils shall be cleaned and sanitized on a predetermined schedule using adequate methods for cleaning and sanitizing.
(6) Sanitizing agents shall be approved, effective and safe under conditions of use, and used only in accordance with the manufacturer's labeling instructions.
(7) Sterilization for multi-use beverage containers must be accomplished prior to refilling by soaking with a 3 percent alkali solution of which not less than 60 percent is caustic for a period of not less than five minutes at a temperature of not less than 130° F., then thoroughly rinsed until freed from alkali.
(8) Any facility, procedure, machine, or device may be acceptable for cleaning and sanitizing equipment and utensils if it is established that such facility, procedure, machine, or device will routinely render equipment and utensils clean and provide adequate sanitizing treatment.
F. Storage and handling of cleaned portable equipment and utensils.
Cleaned and sanitized portable equipment with food-contact surfaces and utensils should be stored in a location and manner that protects food-contact surfaces from contamination.
SECTION VIII. SANITARY FACILITIES AND CONTROLS.
Each plant shall be equipped with adequate sanitary facilities and accommodations including, but not limited to:
A. Water supply.
The water supply shall be sufficient for the operations intended and shall be derived from an adequate source in compliance with applicable water supply regulations adopted by the State Board of Health. Any water that contacts food or food-contact surfaces shall be safe and of adequate sanitary quality. Hot and cold running water under pressure shall be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities,
B. Plumbing.
Plumbing shall be installed in accordance with the Arkansas State Plumbing Code and shall be adequately designed, installed and maintained to:
(1) Carry sufficient quantities of water to required locations throughout the plant.
(2) Properly convey sewage and liquid disposable waste from the plant.
(3) Avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an insanitary condition.
(4) Provide adequate floor drainage in ail areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor.
(5) Provide that there is no backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry potable water for food or food manufacturing or for equipment and utensil cleaning.
C. Sewage disposal.
Sewage disposal shall be made into an adequate and approved sewerage system which is in compliance with applicable wastewater disposal regulations adopted by the State Board of Health.
D. Toilet facilities.
The plant shall be provided with adequate and conveniently located toilets, installed in accordance with the Arkansas State Plumbing Code. The toilet facilities shall be kept clean and in good repair. The toilet room(s) shall be completely enclosed, well lighted, mechanically ventilated to the outside, and equipped with a tight fitting, solid, self closing door.
E. Hand-washing facilities.
Hand-washing facilities shall be provided in each separate food preparation or food processing area, and shall meet the following requirements:
(1) Be located within each separate food preparation or food processing area so as to permit the convenient and expeditious usage by all employees working within that area.
(2) Be provided with hot and cold water under pressure.
(3) Be provided with effective hand-cleaning and sanitizing preparations.
(4) Be provided with sanitary towel service or suitable drying devices.
(5) Devices or fixtures, such as water control valves, shall be so designed and constructed as to protect against re-contamination of clean, sanitized hands.
(6) Provide signs directing employees handling unprotected food, unprotected food-packaging materials, or food-contact surfaces to wash and where appropriate, sanitize their hands before they start to work, after each absence from post of duty, after using the toilet and whenever their hands may have become soiled or contaminated. These signs should be posted in the processing room(s) and in the toilet facilities.
(7) Provide refuse receptacles that are constructed and maintained in a manner that protects against contamination of food, equipment or hands.
F. Rubbish and offal disposal.
Rubbish and any offal shall be so conveyed, stored and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of food, food-contact surfaces, water supplies and ground surfaces.
SECTION X. PROCESSES AND CONTROLS.
A. General sanitation requirements.
All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, processing and storing of food shall be conducted in accordance with adequate sanitation principles. Appropriate quality control operations shall be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable. Overall sanitation of the plant shall be under the supervision of one or more competent individuals assigned responsibility for this function. All reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source. Chemical, microbial or extraneous material testing procedures shall be used where necessary to identify sanitation failures or possible food contamination. All food that has become contaminated to the extent that it is adulterated within the meaning of the Act shall be rejected, or if permissible, treated or processed to eliminate the contamination.
B. Raw materials and other ingredients.
(1) Raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and shall be stored under conditions that will protect against contamination and minimize deterioration. Raw materials shall be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing or conveying shall be safe and of potable quality. Water shall not be reused for washing, rinsing or conveying if it increases the level of contamination of the food. Containers and carriers of raw materials shall be inspected on receipt to ensure that their condition has not contributed to the contamination or deterioration of food.
(2) Raw materials and other ingredients shall either not contain levels of microorganisms that may produce food poisoning or other disease in humans, or they shall be pasteurized or otherwise be treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated within the meaning of the Act. Compliance with this requirement may be verified by any approved means, including purchasing raw materials and other ingredients under a supplier's guarantee or certification.
(3) Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins, pesticides or herbicides, shall comply with current Federal Food and Drug Administration regulations, guidelines, and action levels for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food. Compliance with this requirement may be verified by any approved means, including purchasing raw materials and other ingredients under a supplier's guarantee or certification.
(4) Raw materials, other ingredients and rework susceptible to contamination with pests, undesirable microorganisms or extraneous material shall comply with applicable Federal Food and Drug Administration regulations, guidelines, and defect action levels for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food. Compliance with this requirement may be verified by any approved means, including purchasing raw materials and other ingredients under a supplier's guarantee or certification.
(5) Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed and constructed so as to protect against contamination and shall be held at such temperature and relative humidity and in such a manner as to prevent the food from becoming adulterated within the meaning of the Act. Material scheduled for rework shall be identified as such.
(6) Frozen raw materials and other ingredients shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents the raw materials and other ingredients from becoming adulterated within the meaning of the Act.
(7) Liquid or dry raw materials and other ingredients received and stored in bulk form shall be held in a manner that protects against contamination.
C. Manufacturing operations.
(1) Equipment and utensils and finished food containers shall be maintained in an acceptable condition through appropriate cleaning and sanitizing, as necessary. Insofar as necessary, equipment shall be taken apart for thorough cleaning.
(2) All food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms or for the contamination of food. This may include careful monitoring or physical factors such as time, temperature, humidity, aw, pH, pressure, flow rate and manufacturing operations such as freezing, dehydration, heat processing, acidification and refrigeration to ensure that mechanical breakdowns, time delays, temperature fluctuations and other factors do not contribute to the decomposition or contamination of food.
(3) Food that can support the rapid growth of undesirable microorganisms, particularly those of public health significance, shall be held in a manner that prevents the food from becoming adulterated. Compliance with this requirement may be accomplished by any effective means, including:
(a) Maintaining refrigerated foods at 45 degrees F. (7.2 degrees C) or below or appropriate for the particular food involved.
(b) Maintaining frozen foods in a frozen state.
(c) Maintaining hot foods at 140 degrees F. (60 degrees C) or above.
(d) Heat treating acid or acidified foods to destroy mesophilic microorganisms when those foods are to be held in hermetically sealed containers at ambient temperatures.
(4) Measures, such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling pH or controlling aw that are taken to destroy or prevent the growth of undesirable microorganisms, particularly those of public health significance, shall be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated within the meaning of the Act.
(5) Work-in-process shall be handled in a manner that protects against contamination.
(6) Effective measures shall be taken to protect finished food from contamination by raw materials, other ingredients or refuse. When raw materials, other ingredients, or refuse are unprotected, they shall not be handled simultaneously in a receiving, loading or shipping area if that handling could result in contaminated food. Food transported by conveyor shall be protected against contamination as necessary.
(7) Equipment, containers and utensils used to convey, hold or store raw materials, work-in-process, rework or food shall be constructed, handled and maintained during manufacturing or storage in a manner that protects against contamination.
(8) Effective measures shall be taken to protect against the inclusion of metai or other extraneous material in food. Compliance with this requirement may be accomplished by using sieves, traps, magnets, electronic metal detectors or other suitable effective means.
(9) Food, raw materials and other ingredients that are adulterated shall be disposed in a manner that protects against the contamination of other food. If the adulterated food is capable of being reconditioned, it shall be reconditioned using a method that has been proven to be effective or it shall be re-examined and found not to be adulterated before being incorporated into other food.
(10) Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, de-watering, cooling, shredding, extruding, drying, whipping, de-fatting and forming shall be performed so as to protect food against contamination. Compliance with this requirement may be accomplished by providing adequate physical protection of food from contaminants that may drip, drain or be drawn into the food. Protection may be provided by adequate cleaning and sanitizing of all food-contact surfaces, and by using time and temperature controls at and between each manufacturing step.
(11) Heat blanching, when required in the preparation of food, should be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food to 45o F. or below or passing it to subsequent manufacturing without delay. Thermophilic growth and contamination in bianchers should be minimized by the use of adequate operating temperatures and by periodic cleaning. Where the blanched food is washed prior to filling, water shall be safe and of adequate sanitary quality.
(12) Batters, breading, sauces, gravies, dressings and other similar preparations shall be treated or maintained in such a manner that they are protected against contamination. Compliance with this requirement may be accomplished by any effective means, including the following:
(a) Using ingredients free of contamination.
(b) Employing adequate heat processes where applicable.
(c) Using adequate time and temperature controls.
(d) Providing adequate physical protection of components from contaminants that may drip, drain or be drawn into them.
(e) Cooling to an adequate temperature during manufacturing.
(f) Disposing of batters at appropriate intervals to protect against the growth of microorganisms.
(13) Filling, assembling, packaging and other operations shall be performed in such a way that the food is protected against contamination. Compliance with this requirement may be accomplished by any approved means, including:
(a) Use of a quality control operation in which the critical control points are identified and controlled during manufacturing.
(b) Adequate cleaning and sanitizing of all food-contact surfaces and food containers.
(c) Using materials for food containers and food-packaging materials that are safe and suitable.
(d) Providing physical protection from contamination, particularly airborne contamination.
(e) Using sanitary handling procedures.
(14) Food such as, but not limited to, dry mixes, nuts, intermediate moisture food and dehydrated food, that relies on the control of aw for preventing the growth of undesirable microorganisms shail be processed to and maintained at a safe moisture level. Compliance with this requirement may be accomplished by an effective means, including employment of one or more of the following practices as appropriate:
(a) Monitoring the pH of raw materials, food in process and finished food.
(b) Controlling the soluble solids-water ratio in finished food.
(c) Protecting finished food from moisture pickup, by use of a moisture barrier or by other means, so that the aw of the food does not increase to an unsafe level.
(15) Food such as, but not limited to, acid and acidified food, that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below. Compliance with this requirement may be accomplished by an effective means, including employment of one or more of the following practices as appropriate:
(a) Monitoring the aw of raw materials, food in process, and finished food.
(b) Controlling the amount of acid or acidified food added to low-fat food.
(16) When ice is used in contact with food, it shall be made from water from a source in compliance with applicable water supply regulations adopted by the State Board of Health and shall be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in these regulations, and provisions shall be made for drainage of water produced by melting ice.
(17) Food-manufacturing areas and equipment used for manufacturing human food shall not be used to manufacture non-human food-grade animal feed or inedible products, unless there is no reasonable possibility for the contamination of the human food.
(18) Food manufacturing shall not be performed in place of human residence nor shall manufacturing areas open directly into rooms occupied as residence or sleeping quarters.
(20) Meaningful coding of products sold or otherwise distributed from a manufacturing, processing, packing, or repacking activity shall be utilized to enable positive lot identification to facilitate, where necessary, the segregation of specific food lots that may have become contaminated or otherwise unfit for their intended use. Records should be retained for a period of time that exceeds the shelf life of the product, except that they need not be retained more than two years.
